Electronic-only submissions within the MRP, DCP, and NP are accepted in eCTD or NeeS-format for human medical products and in VNeeS -format for veterinary medical products. If an application is made in an electronic format, subsequent submissions for that product are expected in the same format (unless upgraded from NeeS to eCTD).
Current guidelines for electronic submission must be followed (see Validation below). Please observe that also PDFs not included in the structure (e.g. mock-ups) have to be in PDF version 1.4 or above (preferably 1.4 or 1.7).
For identifying purposes, a paper copy of the cover letter included in the electronic submission should always be attached to the CD/DVD, but an original signature is not needed. The application form can be submitted in electronic format only.
Generally, signatures are not needed to be included (scanned) within the electronic submission.
If the application concerns an extension of a MA, the form “Confirmation for electronic-only submissions” (see Transition to an electronic format) should be attached in order to confirm that documentation for previously approved or submitted strengths and forms of the product will now be handled in electronic format only.
To find more information click the below mentioned web link
The Medical Products Agency (MPA) encourages applicants to use eSubmissions - Additional Administrative Guidance Issued
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